Duration 3 Days

Objective

Good Manufacturing Practice" course is designed for individuals seeking an in-depth understanding of GMP, their role within a management system, and their implementation within the food, pharmaceutical, biotech and other industries. This three-day course provides a detailed overview of the FDA's current GMPs, their role in the hygienic production. Students will gain a detailed understanding of GMPs which can be applied to specific commodities. Participants are led by an experienced instructor to complete workshops and exercises to solidify understanding of GMPs as applicable to their organizations. By the end of the course, participants will be able to implement proven validation solutions and identify current regulatory enforcement trends

Contents

• Introduction to the training course
• Quality management
• Sanitation and hygiene
• Qualification and Validation  
• Complaints and recalls
• Contract production and analysis
• Self-inspection and Quality Audits
• Personnel
• Premises
• Equipment
• Materials
• Documentation (1)  (2) 
• Good Practices in Production and Quality Control
• Sterile production
• Active Pharmaceutical Ingredient
• The role of the inspector
• Preparation for an inspection
• Types of GMP inspection
• The inspection